Directed Systems Limited Announces a Brand-New Version of, and FDA 510(k) Clearance for, Its Operating Room Solution Hypotension Decision Assist (HDA)®

Today, Directed Systems Limited announced that it has received the U.S. Food and Drug Administration (FDA) 510(k) clearance of a brand-new version of the Hypotension Decision Assist (HDA^)® software to be installed on an Advantech medical tablet with networking capabilities. HDA-OR2^TM is designed to help anesthesiologists better manage hypotension during surgery. The new version is smaller, lighter, with a more portable medical-grade tablet and new remote capabilities that provide case review summaries, remote software upgrade capability, and advanced performance metrics via a cloud-based data analytics and reporting platform. This follows the initial FDA 510(k) clearance of the original HDA in November 2019.

FDA 510(k) clearance is a regulatory and premarket submission required by the FDA to allow the sale of the product in the US. HDA-OR2^TM is a uniquely designed clinical decision support Software as a Medical Device (SaMD) that is installed upon a medical-grade touch-screen tablet and supports anesthesiologists by providing intuitive visualization on a single display of at-a-glance time-critical information about emerging critical cardiovascular situations in the operating room. It is indicated for use to assist anesthesia healthcare professionals manage the blood pressure, hemodynamic stability, and the cardiovascular system of patients undergoing surgery and help manage hypotensive episodes and cumulative hypotension during surgery.

With HDA on a smaller, lighter, portable medical-grade tablet, software upgrades can now be installed remotely to further assist medical professionals to easily obtain enhancements and new functionality that improve the overall HDA user experience. The new HDA-OR2 also enables Hypotension Case Review (HCR) to be reviewed at the end of each surgery providing a complete case review summary that visualizes any hypotensive episodes, total cumulative hypotension, and trends of several additional hemodynamic parameters over the entire surgical procedure. It is scrollable and zoomable for time-specific and detailed analysis. Its improved functionality now has additional networking capabilities, able to access cloud-based HDA analytics and reporting platform for in-depth analysis of individual and overall caseload performance metrics.

Episodes of inter-operative hypotension (IOH) are common occurrences in the operating room and are known to occur in over one-quarter of patients undergoing non-cardiac surgery at any time¹. IOH can cause poor outcomes, even death - especially in high-risk patients undergoing surgery² and occur when it falls below certain patient-specific critical thresholds and may increase the risks of organ injury and other adverse outcomes for the patient.¹

"We are delighted that the new Hypotension Decision Assist (HDA-OR2)^TM has achieved FDA 510(k) clearance allowing it to be provided to anesthesiologists and hospitals across the United States to help better manage hypotension during surgery" explained Dr. Mark Leaning CEO and Founder of Directed Systems Limited. "We know that the COVID pandemic has massively interrupted hospitals in their ability to provide surgical services and recognise that there is an ambition now to clear surgical waitlists. We look forward to helping support US hospitals and anesthesiologists to deliver enhanced care for their surgical patients as they aim to reduce surgical waitlists and return to a more normal provision of surgical services for their patient communities."

Gabor Lochte, Sales Director Advantech iHealthcare Europe explained, "It is great that Directed Systems have chosen our 10-inch medical grade tablet pc, the AIM-58, for their hypotension management software. The IP65 protection on the whole system, long battery life up to 8 hours and available not only in the USA but with a MDR certificate for Europe, makes it an ideal combination of the total solution platform. We are looking forward to developing new business opportunities together."

Directed Systems Limited currently sells its HDA-OR2^TM solution in the USA only. HDA is currently not for sale in Europe. Directed Systems Limited is in the process of conducting a clinical investigation with their collaborative partners at Queen Elizabeth Hospital Birmingham, and this will form part of their submission for both EU and UK regulatory approval in Europe and the United Kingdom to enable HDA to enter those markets. The EU and UK launches of HDA are expected in 2022, with a phased local country launch approach across the European countries starting with the UK, Germany, Austria, and Switzerland and then beyond to the remaining EU core markets.

Directed Systems Limited recently showcased the HDA in Europe at the Advantech booth at Medica, Düsseldorf, Germany 15-18 November 2021. HDA will be showcased in the United States for the first time at the 75th Anniversary of the PostGraduate Assembly in Anesthesiology (PGA) in New York City - December 10-13, 2021 on the Bell Medica Booth 617.